Brain Healthy Soul Food Diet Intervention Among Older African Americans

Completed · Not applicable

Conditions studied: Cardiovascular Diseases, Cognitive Decline

In brief

The primary goal of this project is to evaluate feasibility and acceptability of the MIND+SOUL diet and its implementation. Secondary goals of this project are to evaluate cardiovascular risk profile, nutritional health status, and cognition in relation to the MIND+SOUL diet intervention.

Key facts

Study ID

NCT05414682

Run by

University of Kansas Medical Center

People needed

29

Starts

2022-08-01

Expected to finish

2023-11-01

Last updated by the study team

2025-10-20

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Identify as African American or Black
• Age 55 and older
• English Proficient
• 1 or more of the following CVD risk factors (high blood pressure, high cholesterol, overweight/obesity with a BMI of 25 or more)
• Cognitively Normal with an AD8 <2 (normal cognition)

You may not qualify if…

• No CVD risk factors
• AD8 equal to or greater than 2
• Existing diet plan prescribed by a clinician
• Non menopausal (because of DXA scan)
• No internet connection
• Uncontrolled hypertension, by history, or as indicated by supine systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg at the baseline visit. If an initial blood pressure reading is higher than this, an additional attempt (at this visit or on another day) could be used before excluding a patient for uncontrolled hypertension
• Neurological diseases that impact cognition
• Other medical conditions likely to be negatively impacted by a diet change or that could confound the study data
• Unable or unwilling to provide written consent
• PI determination that study is unsafe or unsuitable
• Active depression as determined by a score of 5 or above on the PHQ9 and deemed to be clinically significant by the medical monitor

Where it is running

• University of Kansas Health System — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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